Atlas of Intracranial Recordings on Cortical Responses After Functional tACS

NCT04560959 | Unknown Phase 1 FDA Device

• 1 other identifier: LYS-[2020]-051
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

By analyzing the SEEG recordings, we explore the range of cortical functional responses to strings of 77.5Hz stimulations delivered by tACS,

Conditions

Transcranial Alternating Current Stimulation

Outcome Measures

Primary Outcomes (1)

• Changes of intracranial activities

  The change of the power in a band of 0-200 HZ according to the intracranial EEG recording.

  Within 250 ms immediately after the stimulation.

Secondary Outcomes (2)

• Frequency of the epileptic discharges

  50 minutes during the stimulation and 50 minutes of the interictal baseline before the intervention during the same hour of the day

• Event related potential (ERP)

  Baseline: 24 hours before the tACS intervention; Observation: Immediately after the end of the tACS intervention.

Study Arms (1)

tACS arm

EXPERIMENTAL

The patient would receive strings of tACS stimulations in 77.5 HZ, each string would last for 1 second, followed by an interval of 5 seconds. A total of 600 strings would be sent out to the patients.

Device: tACS

Interventions

tACS DEVICE

tACS would be performed to epilepsy patients who have already received implantation of the SEEG electrodes

tACS arm

Eligibility Criteria

• Age: 14 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All epileptic patients that would receive the implantation of SEEG electrodes, regardless of the seizure locations;
• There was no metal implantation before;
• Eligible for MRI examination;
• No other lesional neurological disorders;
• Could be well informed by the study protocols.

You may not qualify if:

• Suffered from any other mental illnesses prior to the enrollment;
• Those suffering from the serious or unstable organic diseases;
• Pregnant or lactation women, and those who have a plan of pregnant;
• Patients with central nervous system tumors, acute brain injury or infection;
• Skin injured, or allergic to the exposure of the conductive gel;
• Those with implanted devices;
• Those who received modified electrical convulsive therapy, or TMS within the recent one month;
• The score of item 3 (suicidal item) in HAMD-17 equal or greater than 3;
• Enrolled in any other on going trials;
• Other situations evaluated by the researchers as inappropriate to the enrollment

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Related Publications (1)

• Shan Y, Wang H, Yang Y, Wang J, Zhao W, Huang Y, Wang H, Han B, Pan N, Jin X, Fan X, Liu Y, Wang J, Wang C, Zhang H, Chen S, Liu T, Yan T, Si T, Yin L, Li X, Cosci F, Zhang X, Zhang G, Gao K, Zhao G. Evidence of a large current of transcranial alternating current stimulation directly to deep brain regions. Mol Psychiatry. 2023 Dec;28(12):5402-5410. doi: 10.1038/s41380-023-02150-8. Epub 2023 Jul 19.

  PMID: 37468529 DERIVED

Study Officials

• G.G. Zhao

  Department of Neurosurgery, Capital Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

P.H. Wei

CONTACT

+86-010-83198252; weipenghu@xwhosp.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2020
• First Posted: September 23, 2020
• Study Start: September 20, 2020
• Primary Completion: May 1, 2021
• Study Completion: December 1, 2021
• Last Updated: September 23, 2020

Record last verified: 2020-08